title: Effect of a single autologous cord blood infusion on beta-cell and immune function in children with new onset type 1 diabetes: a non-randomized, controlled trial.
abstract: BACKGROUND
  The application of autologous cord blood in children with type 1 diabetes has been found to be safe, but not to preserve beta-cell function in a previous study, which, however, had not included a control group.
  
  
  OBJECTIVE
  To compare the changes of metabolic and immune function over time between cord blood infused children and natural controls.
  
  
  METHODS
  Seven children with newly diagnosed type 1 diabetes underwent a single autologous cord blood infusion and 10 children were enrolled as natural controls in a non-randomized, controlled, open label intervention trial. Primary analyses were performed 1 year following cord blood infusion. Cases and controls were compared regarding metabolic [area under the curve (AUC) and peak C-peptide, insulin use, and HbA1c] and immune outcome (islet autoantibody titer and T-cell response), adjusted for age, gender, diabetes duration, and baseline levels.
  
  
  RESULTS
  There were no significant adverse events related to the infusion. Metabolic and immune outcomes were not significantly different at 12 months follow-up between infused children and controls (e.g., adjusted p = 0.244 for AUC C-peptide, adjusted p = 0.820 for insulin use, adjusted p = 0.772 for peripheral regulatory T cells). Six-month change of AUC C-peptide correlated significantly with the number of infused CD34+ cells (r = 0.931, p = 0.002).
  
  
  CONCLUSIONS
  An autologous cord blood infusion does not change the natural course of metabolic and immune parameters after disease onset. However, the content of CD34+ cells in the stored blood sample might offer potential for improvement of future cell therapies.
authors.affiliation: Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, 85764, Neuherberg, Germany; Forschergruppe Diabetes e.V., 85764, Neuherberg, Germany.
authors.forename: Eleni Z
authors.initials: EZ
authors.lastname: Giannopoulou
authors.forename: Ramona
authors.initials: R
authors.lastname: Puff
authors.forename: Andreas
authors.initials: A
authors.lastname: Beyerlein
authors.forename: Irene
authors.initials: I
authors.lastname: von Luettichau
authors.forename: Heike
authors.initials: H
authors.lastname: Boerschmann
authors.forename: Desmond
authors.initials: D
authors.lastname: Schatz
authors.forename: Mark
authors.initials: M
authors.lastname: Atkinson
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Haller
authors.forename: Dietmar
authors.initials: D
authors.lastname: Egger
authors.forename: Stefan
authors.initials: S
authors.lastname: Burdach
authors.forename: Anette-Gabriele
authors.initials: AG
authors.lastname: Ziegler
mesh_terms: D002648:Child; D002675:Child, Preschool; D036101:Cord Blood Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000276:immunology / Q000378:metabolism / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007107:Immune System / Q000502:physiology*; D007223:Infant; D050417:Insulin-Secreting Cells / Q000502:physiology*; D008297:Male; D014182:Transplantation, Autologous; D016896:Treatment Outcome
keywords: C-peptide; regulatory T-lymphocytes; stem cells